[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8171-8172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2221-N]
RIN 0938-ZA98


Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly 
the Commission on Office Laboratory Accreditation) as a CLIA 
Accreditation Organization

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: In this notice, we grant COLA (formerly the Commission on 
Office Laboratory Accreditation) deeming authority as an accrediting 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) program. We have determined that 
the requirements of the COLA accreditation process are equal to or more 
stringent than the CLIA condition level requirements, and that COLA has 
met the requirements of subpart E of 42 CFR Part 493. Consequently, 
laboratories that are voluntarily accredited by COLA and continue to 
meet COLA requirements will be deemed to meet the CLIA condition-level 
requirements for laboratories and therefore are not subject to routine 
inspection by State survey agencies to determine their compliance with 
Federal requirements. They are, however, subject to Federal validation 
and complaint investigation surveys conducted by us or our designee.

DATES: Effective Date: This notice is effective from February 23, 2007 
to February 25, 2013.

FOR FURTHER INFORMATION CONTACT: Raelene Perfetto, (410) 786-6876.

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative Authority

    On October 31, 1988, the Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA 
replaced in its entirety section 353(e)(2) of the Public Health Service 
Act, as enacted by the Clinical Laboratories Improvement Act of 1967. 
We issued a final rule implementing the accreditation provisions of 
CLIA on July 31, 1992, (57 FR 33992). Under the CLIA program, CMS 
approves a grant of deeming authority to an accreditation organization 
to accredit clinical laboratories if the organization meets certain 
requirements. An organization's requirements for accredited 
laboratories must be equal to, or more stringent than, the applicable 
CLIA program requirements in 42 CFR part 493 (Laboratory Requirements). 
The regulations in subpart E (Accreditation by a Private, Nonprofit 
Accreditation Organization or Exemption Under an Approved State 
Laboratory Program) specify the requirements an accreditation 
organization must meet to be an approved accreditation organization. We 
approve an accreditation organization for a period not to exceed 6 
years.
    In general, the approved accreditation organization must:
    <bullet> Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by us.
    <bullet> Apply standards and criteria that are equal to, or more 
stringent than, those condition-level requirements established by us.
    <bullet> Assure that laboratories accredited by the accreditation 
organization continually meet these standards and criteria.
    <bullet> Provide us with the name of any laboratory that has had 
its accreditation denied, suspended, withdrawn, limited, or revoked 
within 30 days of the action taken.
    <bullet> Notify us at least 30 days before implementing any 
proposed changes in its standards.
    <bullet> If we withdraw our approval, notify the accredited 
laboratories of the withdrawal within 10 days of the withdrawal.
    CLIA requires that we perform an annual evaluation by inspecting a 
sufficient number of laboratories accredited by an approved 
accreditation organization as well as by any other means that we 
determine to be appropriate.

II. Notice of Approval of COLA as an Accreditation Organization

    In this notice, we approve COLA (formerly the Commission on Office 
Laboratory Accreditation) as an organization that may accredit 
laboratories for purposes of establishing their compliance with CLIA 
requirements. We have examined the COLA application and all subsequent 
submissions to determine equivalency with our requirements under 
subpart E of part 493 that an accreditation organization must meet to 
be approved under CLIA. We have determined that COLA complied with the 
applicable CLIA requirements and grant COLA approval as an 
accreditation organization under subpart E, as for the period stated in 
the ``Effective Date'' section of this notice for the following 
specialty and subspecialty areas:
    <bullet> Microbiology, including Bacteriology, Mycobacteriology, 
Mycology, Parasitology, Virology.
    <bullet> Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
    <bullet> Chemistry, including Routine Chemistry, Urinalysis, 
Endocrinology, Toxicology.
    <bullet> Hematology.
    <bullet> Immunohematology, including ABO Group & Rh Group, Antibody 
Detection, Antibody Identification, Compatibility Testing.
    <bullet> Pathology, including Histopathology, Oral Pathology, 
Cytology.
    As a result of this determination, any laboratory that is 
accredited by COLA during the effective time period for an approved 
specialty or subspecialty is deemed to meet the CLIA requirements for 
the laboratories found in part 493 of our regulations and, therefore, 
is not subject to routine inspection by a State survey agency to 
determine its compliance with CLIA requirements. The accredited 
laboratory, however, is subject to validation and complaint 
investigation surveys performed by us, or by any other validly 
authorized agent.

III. Evaluation of COLA Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that 
requirements of the COLA accreditation program are equal to or more 
stringent than the CLIA condition level requirements, and that COLA has 
met the requirements of subpart E of 42 CFR part 493.
    COLA formally reapplied to us for approval as an accreditation 
organization under CLIA for the following specialties and 
subspecialties:

[[Page 8172]]

    <bullet> Microbiology, including Bacteriology, Mycobacteriology, 
Mycology, Parasitology, Virology.
    <bullet> Diagnostic Immunology, including Syphilis Serology, 
General Immunology.
    <bullet> Chemistry, including Routine Chemistry, Urinalysis, 
Endocrinology, Toxicology.
    <bullet> Hematology.
    <bullet> Immunohematology, including ABO Group & Rh Group, Antibody 
Detection, Antibody Identification, Compatibility Testing.
    <bullet> Pathology, including Histopathology, Oral Pathology, 
Cytology.
    We evaluated the COLA application to meet or exceed our 
implementing and enforcement regulations, and the deeming/exemption 
requirements of the CLIA rules.
    We verified that the COLA accreditation program requirements and 
methods require the laboratories it accredits to be, and that the 
organization meets or exceeds the following subparts of part 493 as 
explained below:

Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    COLA submitted the specialties and subspecialties that it would 
accredit; a comparison of individual accreditation and condition-level 
requirements; a description of its inspection process; proficiency 
testing (PT) monitoring process; its data management and analysis 
system; a listing of the size, composition, education and experience of 
its inspection teams; its investigative and complaint response 
procedures; its notification agreements with us; its removal or 
withdrawal of laboratory accreditation procedures; its current list of 
accredited laboratories; and its announced or unannounced inspection 
process.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    COLA's requirements are equal to the CLIA requirements at Sec.  
493.801 through Sec.  493.865. Like CLIA, all of COLA's accredited 
laboratories are required to participate in a CMS-approved proficiency 
test (PT) program for any of tests listed in subpart I. COLA also 
encourages its accredited laboratories to participate in PT for tests 
that are waived under CLIA.

Subpart J--Facility Administration for Nonwaived Testing

    COLA requirements are equal to the CLIA requirements at Sec.  
493.1100 through Sec.  493.1105.

Subpart K--Quality System for Nonwaived Testing

    COLA requirements are equal to the CLIA requirements at Sec.  
493.1200 through Sec.  493.1299. COLA makes educational material 
available to its accredited laboratories, which provide further 
information on quality assurance. As part of good laboratory practice 
and to ensure accuracy, COLA encourages development of a QC program for 
tests that are waived under CLIA.

Subpart M--Personnel for Nonwaived Testing

    COLA states as general policy that its personnel standards for 
accreditation are identical to CLIA. A qualified individual must 
fulfill the responsibilities of each required position in the 
laboratory. The laboratory director and laboratory personnel must meet 
educational and experience requirements. Although certain duties of the 
laboratory director may be delegated to qualified individuals, the 
laboratory director remains ultimately responsible. We have determined 
that COLA requirements are equal to the CLIA requirements at Sec.  
493.1403 through Sec.  493.1495 for laboratories that perform moderate 
and high complexity testing.

Subpart Q--Inspections

    We have determined that the COLA requirements are equal to the CLIA 
requirements at Sec.  493.1771 through Sec.  493.1780. COLA will 
continue to perform onsite inspections every 2 years.

Subpart R--Enforcement Procedures

    COLA meets the requirements of subpart R to the extent that it 
applies to accreditation organizations. COLA policy sets forth the 
actions the organization takes when laboratories it accredits do not 
comply with its requirements and standards for accreditation. When 
appropriate, COLA will deny, suspend, or, revoke accreditation in a 
laboratory accredited by COLA and report that action to us within 30 
days. COLA also provides an appeal process for laboratories that have 
had accreditation denied, suspended, or revoked.
    We have determined that COLA's laboratory enforcement and appeal 
policies are equal to the requirements of part 493 subpart R as they 
apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The Federal validation inspections of COLA accredited laboratories 
may be conducted on a representative sample basis or in response to 
substantial allegations of noncompliance (that is, complaint 
inspections). The outcome of those validation inspections, performed by 
us or our agents, the State survey agencies, will be our principal 
means for verifying that the laboratories accredited by COLA remain in 
compliance with CLIA requirements. This Federal monitoring is an 
ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of COLA, for cause, before the 
end of the effective date of approval. If we determine that COLA failed 
to adopt requirements that are equal to, or more stringent than, the 
CLIA requirements, or that systemic problems exist in its inspection 
process, we may give it a probationary period, not to exceed 1 year to 
allow COLA to adopt comparable requirements.
    Should circumstances result in our withdrawal of the COLA's 
approval, we will publish a notice in the Federal Register explaining 
the basis for removing its approval.

VI. Collection of Information Requirements

    This notice does not impose any information collection and record 
keeping requirements subject to the Paperwork Reduction Act (PRA). 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with the accreditation process for clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program, codified in 42 CFR part 493 subpart E, are 
currently approved by OMB under OMB approval number 0938-0686.

VII. Executive Order 12866 Statement

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Section 353 of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: December 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-3025 Filed 2-22-07; 8:45 am]
BILLING CODE 4120-01-P